Regulatory expert Steven Grossman shares his views on the recent US Presidential election and how this decision will affect the FDA and the healthcare industry this year.
Looking back over the last 40 years at FDA (as I have), there are three characteristics that create a more...
Regulatory expert Steven Grossman shares his views on the recent US Presidential election and how this decision will affect the FDA and the healthcare industry this year.
Looking back over the last 40 years at FDA (as I have), there are three characteristics that create a more...
Steven Grossman

FDA Matters

With the recent re-election of Barrack Obama as President of the United States, Steven Grossman shares his views on the affect this will have on the healthcare industry, and more specifically on the regulatory body, the FDA.

Looking back over the last 40 years at FDA (as I have), there are three characteristics that create a more progressive environment at the agency: continuity of leadership, presidential support, and increased funding. For FDA in 2013 (as the saying goes): 2 out of 3 ain’t bad.

Obama wins

Newly-re-elected Presidents almost always stress changes in personnel, policies and priorities, instead of what one would expect: continuity. In many ways, year 5 is a partial re-play of year 1.

Multiple cabinet offices, State, Defense, Treasury, Interior, Energy, and the Environmental Protection Agency, are losing their leadership and replacements need to be confirmed by the US Senate. The Administration’s focus on budget and fiscal matters is rapidly shifting toward creating a legacy larger than constant fighting with House Republicans.

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"The greatest fear I have heard is that the FDA will suddenly turn regulation-happy…"

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On the policy front, gun violence and immigration will be new spotlight items, while jobs and unemployment will get renewed attention. Implementing ObamaCare will likewise be a key priority, as major provisions of the law go into effect over the next few years.

While trying to provide new leadership and simultaneously solidifying his mandate, the newly re-elected President will still be dealing with a hostile House of Representatives and a sharply divided Senate.

FDA focuses

Not all of the government changes just because the President has a new mandate. The greatest fear I have heard is that the FDA will suddenly turn regulation-happy and start a major push to burden industry. Not only is this unlikely, every indication is the opposite.

The entire tenor of Commissioner Hamburg’s tenure — public statements and actions — has been to try to create more science-based decision making, publish more guidance for industry, and to listen to Congress, industry and patients about FDA’s role in supporting medical innovation.

And this is where the major “change” at FDA will come as a result of the election. It looks like Commissioner Hamburg will be staying and she will have the time to follow-through on the many policies, approaches and organizational structures she has championed. May 2013 marks four years since her confirmation. This is the longest tenure for an FDA commissioner since Dr. David Kessler ran the agency for slightly more than 6 years in the 1990’s.

Thus, if there is more regulation in 2013 and 2014, it will be largely to satisfy the legal requirements of the three new laws passed by Congress on a bi-partisan basis over the last few years — food safety modernization, biosimilars, and reforms contained in the latest PDUFA (user fee) reauthorization. In addition, Congress may also — by legislation or political pressure — push the agency into taking more regulatory approaches to drug shortages, track and trace / counterfeits, and pharmaceutical compounding.

Innovation benefits from continuity

Apart from these regulatory initiatives, 2013 looks very much like “springtime” for innovative approaches to medical product approvals. Efforts to implement the biosimilars legislation have been predictably slow, but are definitely moving forward. On a faster track, FDA is moving quickly to find ways to speed the best drug candidates toward earlier decisions and, presumably, more approvals.

For example, FDA has jumped quickly into designating “breakthrough drugs” for special attention, as provided for in the FDASIA legislation. It could have taken years if FDA had been reluctant, instead the first designations came less than 6 months after the law was signed by the President.

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"...2013 looks very much like “springtime” for innovative approaches to medical product approvals."

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Even more aggressively: FDA has reportedly been working with stakeholders on a program that might permit “limited use approvals” in areas of particularly serious unmet medical need. The original focus has been on antibiotics, but with the clear understanding that the concept is a failure if it can’t be more broadly applied in other therapeutic categories.

The President has FDA’s back

As has been described, President Obama will have a full plate, little, if any, of his mandate will benefit FDA. Nonetheless, this is a President who understands public health and realizes that it has value. The President has consistently requested greater funding for FDA and was not over his head when he had to handle the “peanut butter crisis” during his first months in office when there was neither a Secretary of Health and Human Services nor a Commissioner in place.

While this is hardly a strong public health resume, it contrasts sharply with his predecessors going back to President Carter in the 1970’s— none of whom had any interest in public health while in office. Ironically, Presidents Carter and Clinton became associated with public health causes, but only after they left office. They did little for FDA while they were President.

Money will restrain FDA and may even cause it to regress.

As this is written, FDA faces the potential of losing about $200 to $250 million from its current year (FY 13) budget. This retrenchment, which could occur as early as March 1, will be severe, particularly because the agency’s primary expense is its people. Over 80% of the agency’s budget is for salaries, benefits, training, travel, etc. Funding cutbacks will, inevitably, require loss of personnel and inability to provide essential FDA services.

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"…this is a President who understands public health and realizes that it has value."

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Even if this “sequestration” cut does not occur, funding of discretionary federal programs will be under intense pressure for years to come. Status quo funding may be manageable (if unpleasant) for many agencies, but could be ruinous for an FDA whose challenges and responsibilities continue to grow. (Those interested in joining the fight for increased FDA funding, should consider joining the Alliance for a Stronger FDA at www.StrengthenFDA.org.)

Conclusion

While it is inevitable that FDA will always have its critics, Commissioner Hamburg’s leadership has been progressive and productive for most stakeholders. With the possible exception of the medical device approval process (which I believe is slowly improving) …..all the major areas of agency responsibility are in a transition from “constant complaints” to “how can we do better.” This is only possible with leadership continuity and Presidential support. Only the prospect of funding shortfalls stands in the way.

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About the author:

Steven A. Grossman is president of HPS Group, LLC (www.hpsgroup.com), a strategic public affairs and regulatory consulting firm located in Silver Spring, MD. As part of his consulting practice, he is the author and publisher of the blog, FDA Matters (www.fdamatters.com). He is also Deputy Executive Director of the Alliance for a Stronger FDA, a 200-member multi-stakeholder advocacy group that supports increased appropriated funding for the FDA (www.StrengthenFDA.org)

Earlier in his career, Mr. Grossman was a Deputy Assistant Secretary for Health at DHHS and Health Staff Director and Majority Counsel to the Senate Committee on Labor and Human Resources (now Senate HELP Committee). He was one of the chief Senate negotiators on the Orphan Drug Act of 1983 and on the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman).